Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track

Sigmoid Neoplasms Clinical Trial

Official title:

Length of Hospital Stay, Nursing Hours and Recovery After Laparoscopic Versus Open Colon Resection Without Fast Track

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01127425
• Other study ID #: KA-20060067
• Status: Terminated
• Phase: N/A
• First received: February 17, 2010
• Last updated: June 4, 2010
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: June 2006
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

A blinded randomized trial. Length of hospital stay, nursing hours and recovery after laparoscopic versus open colonic resection without fast track.

Description:

CONTEXT: Our preliminary experience (unpublished) indicate that less nursing hours are needed after laparoscopic colon resection without fast track. Length of hospital stay and recovery seems to be reduced as well.

OBJEKTIVE: To compare laparoscopic and open colonic resection concerning nursing hours, length of hospital stay and recovery.

DESIGN, SETTING AND PATIENTS: triple blinded study (Patient, nursing staff and data collector) including 2 x 12 patients needing sigmoid resection due to cancer. Nursing hours, length of hospital stay and recovery (postoperative pain, questionnaire, actigraph ect.)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• sigmoid resection without stoma

• sigmoid neoplasms localized 20 cm from anus

• age 40-90

Exclusion Criteria:

• conversion from laparoscopic to open surgery

• stoma

• severe postoperative complications (anastomosis leak, intraabdominal abscess, reoperation, stay at intensive care unit, heart attack, pulmonary embolism)

• no informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sigmoid Neoplasms

Intervention

Procedure:
• laparoscopic colonic resection
Conventional surgery compared to laparoscopic sigmoid resection
• laparoscopic sigmoid resection
sigmoid resection by laparoscopic surgery

Locations

Country	Name	City	State
Denmark	University Hospital of Gentofte, gastroenterologic surgery	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary: Length of stay		1 year	No
Secondary	secondary: Nursing hours, pain and recovery		1 year	No